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A Personalized, Digital Coaching Program After Stroke (STROKECOACH)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03038685
First Posted: February 1, 2017
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Sint-Lucashospital, Bruges, Belgium
AZ Sint-Jan AV
Groeningehospital, Kortrijk, Belgium
Belgian Stroke Council
Interuniversity Centre For Health Economics Research, VUB, Brussels, Belgium
Information provided by (Responsible Party):
PVanacker, University Hospital, Antwerp
  Purpose
The Belgian Stroke Council initiated a project to improve risk factor control and medication adherence in ischemic stroke patients by developing an individualized in-hospital initiated and post- discharge, digital coaching program addition to standard practice (strokecoach.be).

Condition Intervention
Stroke, Ischemic Behavioral: Strokecoach.be - digital coaching program for stroke patients

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
A pilot, double-arm, pre/post study design with compirason between historical, monocenter cohort (Sint-Janhospital, 2011) and prospective, multicenter cohort (4 Belgian Stroke centers, 2017)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Personalized, Digital Coaching Program With Teleconsultancy to Improve Secondary Prevention After Ischemic Stroke: a Pilot, Multicenter Pre/Post Study.

Further study details as provided by PVanacker, University Hospital, Antwerp:

Primary Outcome Measures:
  • cardiovascular risk factor control [ Time Frame: 6 months ]
    The primary endpoint is the impact of the intervention on the cardiovascular risk factor control by assessing the evolution of the SCORE (Systematic COronary Risk Evaluation: High & Low cardiovascular Risk Charts) risk pre- and postintervention. An official program to analyze these parameter will be used (AOST©, Crethsoft).


Secondary Outcome Measures:
  • Quality-of-life [ Time Frame: 3-6months ]
    The impact on the quality-of-life will be evaluated by using the dutch version of the EQ-5D questionnaire

  • Clinical outcome [ Time Frame: 6 months ]
    The impact on the clinical outcome will be assessed by the modified Rankin Score (0-6, mRS).

  • Stroke recurrence rate [ Time Frame: 0.5-1-2-3-6 months ]
    At every teleconsultancy contact stroke recurrences will be demanded.

  • Therapeutic adherence [ Time Frame: 0.5-1-2-3-6 months ]
    A selfreport of the therapeutic adherence will be checked at every consultation by asking them if any medication had been skipped during last 10 days.


Enrollment: 148
Actual Study Start Date: May 1, 2017
Estimated Study Completion Date: February 28, 2018
Estimated Primary Completion Date: February 28, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: prospective, multicenter cohort
A group of 175 patients will be recruited in 4 Belgian stroke centers during the six months period. All data will be collected prospectively and patients will be treated during six months period.
Behavioral: Strokecoach.be - digital coaching program for stroke patients
The stroke coach gives patients two education sessions during hospitalization (risk factor management, review of medications and clinical evolution). During these sessions, study participation will be proposed. Eligibility will partially depend on their historical use of the internet and e-mail. The aim is to have the digital platform personalized for his/her individual needs, risk factors and remaining neurologic signs/symptoms. Tips and tricks to deal with lifestyle modification will be delivered on regular basis. Meanwhile, patients will be asked to complete on a pre-specified frequency their data regarding their cardiovascular risk profile. Additionally, participants will be contacted at 0.5-1-2 and 6 months by phone calls or videoconsultancy. To standardize, an adapted, digital version of the standardized WSO Post-Stroke Checklist shall be used as a decision-support flowchart. A report of the consultation will be derived after the videoconsultancy.
No Intervention: historical, single center cohort
A historical cohort of Sint-Janhospital (2011 - Bruges, Belgium) with prospectively collected data will be used as comparator for the experimental arm. These data were published in Vanacker P, Couvreur T, Vanhooren G. Can we improve cerebrovascular risk reduction in real-life? A single centre's experience. Cerebrovasc Dis 2011;31(suppl 2):289

Detailed Description:

The overall aim of this project is to further improve subacute and chronic stroke care in the Belgian context with main focus on the patients' quality of life, stroke recurrence and secondary cardiovascular prevention. Main focuses are on patient-empowerment, shared-decision making and health literacy, as these items are linked with better therapeutic adherence and self-care for chronic diseases.

In case of a positive result, implementation of this individualized chronic stroke care program executed by a personal stroke coach, initiated during hospitalization and using a web-based intervention program, can easily be unrolled in other Belgian stroke units. The program can be cost-effective if better clinical outcome, stroke recurrence rates, number of in-hospital consultations, number of rehospitalisations are reduced. This will be evaluated in a in-depth healt-economic analysis.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with an acute ischemic stroke hospitalized at a participating stroke center can be included during hospitalisation if fulfilling following three criteria: - they will return back home or be discharged to a rehabilitation center

  • have a life expectancy of more than 6 months
  • have experience with internet use (at least weekly checking emails) or a caregiver accepts to help with the digital platform.

Exclusion Criteria:

  • Age < 18 years
  • Patients unable or unwilling to be followed post-discharge for 6 months
  • Patients with a major neurologic post-stroke and no caregiver participation
  • Cognitive impairment limiting use of digital platform and no caregiver participation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038685


Locations
Belgium
Sint-Janhospital
Brugge, Belgium, 8000
Sint-Lucashospital
Brugge, Belgium, 8310
University Hospital Antwerp
Edegem, Belgium, 2650
Groeningehospital
Kortrijk, Belgium, 8500
Sponsors and Collaborators
University Hospital, Antwerp
Sint-Lucashospital, Bruges, Belgium
AZ Sint-Jan AV
Groeningehospital, Kortrijk, Belgium
Belgian Stroke Council
Interuniversity Centre For Health Economics Research, VUB, Brussels, Belgium
Investigators
Principal Investigator: Peter Vanacker, MD PhD University Hospital, Antwerp
  More Information

Responsible Party: PVanacker, neurovascular consultant, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03038685     History of Changes
Other Study ID Numbers: UHAntwerp
First Submitted: January 30, 2017
First Posted: February 1, 2017
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by PVanacker, University Hospital, Antwerp:
Secondary prevention
Web-based intervention
Strokecoach

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes